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Pharmacokinetics, Safety, and Tolerability of rhEGF Eye Drops in Healthy Male Subjects

NCT05219461 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-02-02

No results posted yet for this study

Summary

A randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of the Pharmacokinetics, safety, and tolerability of rhEGF eye drops in healthy male subjects

Conditions

  • Dry Eye Syndromes

Interventions

DRUG

Single dose of rhEGF 10mcg/ml or placebo

6 subjects will be assigned to rhEGF 10mcg/ml eye drop and 2 subjects will be assigned to placebo

DRUG

Single dose of rhEGF 50mcg/ml or placebo

6 subjects will be assigned to rhEGF 50mcg/ml eye drop and 2 subjects will be assigned to placebo

DRUG

Single dose of rhEGF 100mcg/ml or placebo

6 subjects will be assigned to rhEGF 100mcg/ml eye drop and 2 subjects will be assigned to placebo

DRUG

Multiple dose of rhEGF 10mcg/ml or placebo

6 subjects will be assigned to rhEGF 10mcg/ml eye drop and 2 subjects will be assigned to placebo

DRUG

Multiple dose of rhEGF 50mcg/ml or placebo

6 subjects will be assigned to rhEGF 50mcg/ml eye drop and 2 subjects will be assigned to placebo

DRUG

Multiple dose of rhEGF 100mcg/ml or placebo

6 subjects will be assigned to rhEGF 100mcg/ml eye drop and 2 subjects will be assigned to placebo

Sponsors & Collaborators

  • Daewoong Bio Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
51 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-29
Primary Completion
2019-11-13
Completion
2019-11-13

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05219461 on ClinicalTrials.gov